CD19-CAR T Cells(Institute of Hematology & Blood Diseases Hospital)

– No CRS or ICANS of any grade observed during the 28-day DLT observation window for either of the first patients dosed with CABA-201 in the RESET-Myositis™ and RESET-SLE™ trials – – Initial clinical data from each of the first patients in the RESET-Myositis and RESET-SLE trials to be presented at a satellite symposium at the EULAR 2024 Congress in June – – Evaluating CABA-201 without preconditioning by initiation of the RESET-PV™ sub-study within the ongoing DesCAARTes™ trial in pemphigus vulgaris – PHILADELPHIA, May 15, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the first quarter ended March 31, 2024, and provided a business update. “With no CRS or ICANS of any grade observed in either of the first patients from the RESET-Myositis and RESET-SLE trials, we look forward to presenting initial translational and clinical data from both patients during a satellite symposium at the EULAR 2024 Congress on June 14th,” said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. “In addition to implementing our development path for CABA-201, we have made substantial progress on two innovations designed to optimize the patient and physician experience. First, we are evaluating CABA-201 without preconditioning through the incorporation of the RESET-PV sub-study within the ongoing DesCAARTes trial in patients with pemphigus vulgaris, expanding CABA-201 development into dermatology. Second, we demonstrated the potential to eliminate the need for apheresis by using a blood draw to obtain the starting material for the CABA-201 manufacturing process as presented at the ASGCT meeting. We are evaluating the opportunity to incorporate an apheresis-free process into our ongoing CABA-201 clinical program. By executing on our CABA-201 development strategy and integrating these types of innovations, we believe that we are well positioned to deliver on the full potential of the targeted cell therapies that we are developing to provide durable, drug-free remissions for patients with a broad range of autoimmune diseases.” Recent Operational Highlights and Upcoming Anticipated Milestones Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) Strategy CABA-201: Autologous, engineered T cells designed with a chimeric antigen receptor containing a fully human CD19 binder and a 4-1BB co-stimulatory domain as a potential treatment for a broad range of autoimmune diseases across multiple therapeutic portfolios where B cells contribute to the initiation and/or maintenance of disease. Rheumatology Portfolio Myositis (idiopathic inflammatory myopathies) In March 2024, Cabaletta announced the first patient had been dosed in the Phase 1/2 RESET-Myositis trial. No evidence of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was observed during the 28-day dose-limiting toxicity (DLT) observation window following administration. Patient enrollment in the Phase 1/2 RESET-Myositis trial is ongoing and initial clinical data from the first patient is anticipated to be presented in a satellite symposium at the EULAR 2024 Congress in June. During the first quarter of 2024, Cabaletta announced that the U.S. Food and Drug Administration (FDA) granted regulatory designations to CABA-201 in myositis, including Fast Track Designation for the treatment of patients with dermatomyositis, Orphan Drug Designation for the treatment of idiopathic inflammatory myopathies (IIM, or myositis) and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. Systemic lupus erythematosus (SLE) The first patient has been dosed in the Phase 1/2 RESET-SLE trial. No evidence of CRS or ICANS of any grade was observed during the 28-day DLT observation window following administration. Patient enrollment in the Phase 1/2 RESET-SLE trial is ongoing and initial clinical data from the first patient is anticipated to be presented in a satellite symposium at the EULAR 2024 Congress in June. In March 2024, Health Canada issued a No Objection Letter in response to a Clinical Trial Application for the RESET-SLE trial submitted by Cabaletta, enabling the Company to begin the process to activate clinical trial sites and pursue patient enrollment for the RESET-SLE trial in Canada. Systemic sclerosis (SSc) During the first quarter of 2024, Cabaletta announced that the FDA granted regulatory designations to CABA-201 in SSc, including Fast Track Designation for the treatment of patients with SSc and Orphan Drug Designation for the treatment of SSc. Cabaletta expects to report initial clinical data from the Phase 1/2 RESET-SSc™ trial in the second half of 2024. Dermatology Portfolio Pemphigus vulgaris (PV) Cabaletta is working with active clinical sites to incorporate the RESET-PV sub-study within the Phase 1 DesCAARTes trial following the submission of a protocol amendment. The RESET-PV sub-study will evaluate CABA-201 as a monotherapy without preconditioning in patients with mucosal PV (mPV) and mucocutaneous PV (mcPV). Neurology Portfolio Generalized myasthenia gravis (gMG) Cabaletta expects to report initial clinical data from the Phase 1/2 RESET-MG™ trial in the second half of 2024. Past and Upcoming External Scientific Presentations In May 2024, Cabaletta presented new preclinical data at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting demonstrating the ability to manufacture autologous CD19-CAR T cells from a blood draw as a potential alternative to apheresis. Whole blood collections from 80mL to 200mL were successfully used in lieu of apheresis material to produce CAR T cells that demonstrated similar growth, viability, memory phenotype and cytotoxicity across 3 healthy donors. In addition, CD19-CAR T cells were manufactured successfully from whole blood sourced from 2 lupus patients and showed expected T cell memory subtype and cytotoxic functionality. In June 2024, Cabaletta plans to present initial clinical data from each of the first patients treated with CABA-201 in the RESET-Myositis and RESET-SLE trials in a EULAR European Congress of Rheumatology 2024 Industry Symposia session titled “Immune Reset: The Potential of CAR T Cell Therapy to Transform the Treatment of Patients with Autoimmune Disease” at 8:15 a.m. CEST on Friday, June 14, 2024, in Vienna, Austria. Chimeric AutoAntibody Receptor T (CAART) cells Strategy DSG3-CAART: Cabaletta is evaluating desmoglein 3 chimeric autoantibody receptor T (DSG3-CAART) cells as a potential treatment for patients with mPV. The DesCAARTes trial is not currently dosing patients with DSG3-CAART as we evaluate clinical and translational data from the combination cohort, where patients were pre-treated with IVIg, cyclophosphamide and fludarabine prior to DSG3-CAART infusion, with the aim of improving persistence and activation of DSG3-CAART compared to findings from the no preconditioning cohorts previously reported. MuSK-CAART: Cabaletta is evaluating muscle-specific kinase (MuSK) chimeric autoantibody receptor T (MuSK-CAART) cells as a potential treatment for patients with MuSK-associated myasthenia gravis (MuSK MG). The MusCAARTes™ trial is not currently dosing patients as we evaluate clinical and translational data from the A1 and A2 cohorts, where patients were treated with MuSK-CAART without preconditioning. Upcoming Investor Events Cabaletta plans to participate in the following upcoming investor conferences: H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ, which is being held on May 20, 2024 in New York, NY. Jefferies Global Healthcare Conference, which is being held from June 5-6, 2024 in New York, NY. Goldman Sachs 45th Annual Global Healthcare Conference, which is being held from June 10-13, 2024 in Miami, FL. First Quarter 2024 Financial Results Research and development expenses were $22.0 million for the three months ended March 31, 2024, compared to $12.4 million for the same period in 2023. General and administrative expenses were $6.1 million for the three months ended March 31, 2024, compared to $4.5 million for same period in 2023. As of March 31, 2024, Cabaletta had cash, cash equivalents and short-term investments of $223.8 million, compared to $241.2 million as of December 31, 2023. The Company expects that its cash, cash equivalents and short-term investments as of March 31, 2024, will enable it to fund its operating plan into the first half of 2026. About CABA-201 CABA-201 is designed to deeply and transiently deplete CD19-positive B cells following a one-time infusion, which may enable an “immune system reset” with the potential for durable remission without chronic therapy in patients with autoimmune diseases. Cabaletta is evaluating CABA-201 in multiple autoimmune conditions including systemic lupus erythematosus (SLE), myositis, systemic sclerosis (SSc), generalized myasthenia gravis (gMG) and pemphigus vulgaris (PV). Cabaletta is conducting four Phase 1/2 RESET™ clinical trials evaluating CABA-201 with a total of nine cohorts that can advance simultaneously, employing a similar parallel cohort design and starting dose of 1 x 106 cells/kg without a dose escalation requirement. CABA-201 is also being evaluated in the absence of preconditioning in a separate sub-study within the DesCAARTes™ trial for patients with PV. About Cabaletta Bio Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis and in the RESET-PV™ sub-study within the DesCAARTes™ clinical trial in pemphigus vulgaris, along with the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK-associated myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. Forward-Looking Statements This press release contains “forward-looking statements” of Cabaletta Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding: Cabaletta’s ability to grow its autoimmune pipeline; Cabaletta’s future plans and strategies for its CAAR T and CARTA technologies and the company’s business plans and objectives as a whole; statements regarding regulatory filings for its development programs, including the planned timing of such regulatory filings and potential review by regulatory authorities; Cabaletta’s ability to retain and recognize and its expectations around the intended incentives conferred by Fast Track Designation and/or Orphan Drug Designation for CABA-201 for the treatment of multiple autoimmune diseases; Cabaletta’s ability to retain and recognize and its expectations around the potential benefits and incentives provided by FDA’s rare pediatric disease designation for CABA-201; Cabaletta’s expectations around the potential success and therapeutic benefits of CABA-201, including its belief that CABA-201 may enable an “immune system reset” with the potential for durable remission without chronic therapy in patients with autoimmune diseases; the Company’s advancement of separate Phase 1/2 clinical trials of CABA-201 in patients with SLE, myositis, SSc and gMG and advancement of a RESET-PV sub-study within the ongoing DesCAARTes trial in PV, including updates related to status, safety data, or otherwise and the expected timing of the related data read-outs; Cabaletta’s plans to eliminate the need for apheresis by using a simpler collection process to obtain the starting material for the CABA-201 manufacturing process; Cabaletta’s ability to accelerate its pipeline, develop meaningful therapies for patients and leverage its research and translational insights; the Company’s expectations for the efficiency of the trial design for its Phase 1/2 clinical trials of CABA-201 and for its RESET-PV sub-study within the ongoing DesCAARTes trial in PV; Cabaletta’s planned initial clinical data read-out at the EULAR 2024 Congress in June 2024 for patients with myositis and SLE treated with CABA-201; Cabaletta’s additional planned initial clinical data read-outs for patients with SSc and gMG treated with CABA-201 or otherwise; Cabaletta’s advancement of the process to activate clinical trial sites and pursue patient enrollment for the RESET-SLE trial in Canada; Cabaletta’s planned assessment of its DesCAARTes™ and MusCAARTes™ trials; use of capital, expense and other financial results in the future; ability to fund operations into the first half of 2026 and the anticipated contribution of the members of Cabaletta’s executives to the company’s operations and progress. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to regulatory filings and potential clearance; the risk that signs of biologic activity or persistence may not inform long-term results; Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical studies and clinical trials of CABA-201; the risk that the results observed with the similarly-designed construct employed in academic publications, including due to the dosing regimen, are not indicative of the results we seek to achieve with CABA-201; risks related to clinical trial site activation, delays in enrollment generally or enrollment rates that are lower than expected; delays related to assessment of clinical trial results; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to volatile market and economic conditions and public health crises; Cabaletta’s ability to retain and recognize the intended incentives conferred by Orphan Drug Designation and Fast Track Designation or other designations for its product candidates, as applicable; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; risks related to fostering and maintaining successful relationships with Cabaletta’s collaboration and manufacturing partners, including in light of recent legislation; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabaletta’s product candidates will not be successfully developed and/or commercialized; and the risk that the initial or interim results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law. CABALETTA BIO, INC. SELECTED FINANCIAL DATA (unaudited; in thousands, except share and per share data) Statements of Operations Three Months Ended March 31, 2024 2023 Unaudited Operating expenses: Research and development $ 21,954 $ 12,435 General and administrative 6,077 4,521 Total operating expenses 28,031 16,956 Loss from operations (28,031 ) (16,956 ) Other income: Interest income 2,984 1,102 Net loss (25,047 ) (15,854 ) Net loss per share of voting and non-voting common stock, basic and diluted $ (0.51 ) $ (0.45 ) Selected Balance Sheet Data March 31, 2024 December 31, 2023 (unaudited) Cash, cash equivalents and investments $ 223,845 $ 241,249 Total assets 240,457 253,650 Total liabilities 18,737 17,452 Total stockholders’ equity 221,720 236,198 Contacts: Anup Marda Chief Financial Officer investors@cabalettabio.com William Gramig Stern Investor Relations, Inc. william.gramig@sternir.com

TORONTO, April 11, 2024 (GLOBE NEWSWIRE) -- The Gairdner Foundation is pleased to announce the 2024 Canada Gairdner Award laureates, recognizing some of the world’s most significant biomedical and global health research and discoveries. “Canada is a world leader in science and innovation, and it is crucial to recognize the hard work done by its scientific community to make the world around us better. The 2024 Canada Gairdner Awards recipients’ contributions to science and research are truly exemplary, standing out on the global stage. The work of these laureates will most definitely improve the health of people in Canada and around the world. Congratulations to this year’s recipients!” - The Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry “Congratulations to the recipients of the 2024 Canada Gairdner Awards who are being recognized for scientific discoveries that have transformed biomedical science, medicine, and global health. I’d like to give special mention to the Canadian recipients of this year’s Canada Gairdner Momentum Awards, Dr. Meghan Azad and Dr. Christian Landry. The outstanding work of these researchers will have a profound and lasting impact on the health of people in Canada and around the world.” – The Honourable Mark Holland, Minister of Health “The Gairdner Awardees showcase the world’s best science and innovation to improve human health. This year is no exception. Join us to get to know these exceptional individuals and their passions.” - Rémi Quirion, Scientifique en chef du Québec Président des CA des Fonds de recherche du Québec, partenaires de la Fondation Gairdner 2024 Canada Gairdner International Award The five 2024 Canada Gairdner International Award laureates are recognized for seminal discoveries or contributions to biomedical science: Zelig Eshhar, PhDWeizmann Institute of Science, Rehovot, Israel Michel Sadelain, MD, PhDDirector, Center for Cell Engineering, Stephen and Barbara Friedman Chair, Sloan Kettering Institute, Memorial Sloan Kettering Cancer Center, New York, NY, USA Awarded “For seminal contributions to the conception, development and application of CD19-CAR T cell therapy for cancer.” The Work: Chimeric antigen receptor (CAR) T cell therapy is a type of cancer immunotherapy. It uses immune cells, called T cells, that are genetically altered in the lab to enable them to locate and destroy cancer cells. Both Eshhar’s and Sadelain’s trailblazing research into CAR T cell engineering spans many decades. Their combined efforts defined the pathway for the future of cellular immunotherapy to treat cancer. Eshhar has focused his career around the genetic engineering of T cells. These studies led him to predict that combining the killing machinery of cytotoxic T cells with an antibody’s specificity and high affinity to a target, would lead to new T cell-based therapies. He developed the first chimeric antigen receptor system in the 1980s and introduced it into T cells armed with an anti-tumor specificity. Eshhar went on to demonstrate the ability of such CAR T cells to successfully treat cancer in animal models. Sadelain began investigating what would eventually be referred to as CAR T cell therapy in the late 1980s, publishing his first abstract on successful T-cell engineering in 1992. Over the next decade, Sadelain and his team improved upon Eshhar’s design and by 2002 built the first truly effective CAR T cells, paving the way for their clinical use. Key to this breakthrough was the demonstration that CD19, a molecule on white blood cells, could serve as an effective target for CAR T cells in blood-borne cancers. These second-generation CAR T cells were able to survive, proliferate and kill cancer cells in the lab, which established the feasibility and proof of concept for producing genetically instructed, targeted immune responses. In 2003, Sadelain and his colleagues published a seminal research paper showing that human CD19-directed CAR T cells could eradicate leukemia cells in a mouse model. Soon afterwards, clinical trials led by different groups, including Dr. Sadelain’s, demonstrated that the tumor burden in refractory chronic lymphocytic leukemia and adult and pediatric acute lymphoblastic leukemia could be successfully reduced and eventually become undetectable. The first CAR T cell therapies, targeting CD19, were approved by the U.S. Food and Drug Administration in 2017 for use in children and young adults with refractory acute leukemias and certain refractory lymphomas. The Impact: Currently, CAR T cell products have been approved worldwide for multiple indications, including large B-cell lymphoma, B-cell acute lymphoblastic leukemia, mantle cell lymphoma and follicular lymphoma. CAR T cell therapy has revolutionized the treatment landscape of relapsed and refractory B-cell malignancies. In contrast to conventional cytotoxic chemotherapy or immunotherapy with monoclonal antibodies, CAR T-cell therapy can induce durable and complete responses after a single treatment course. Such responses stem from the ability of CAR T cells to expand in vivo and persist for several months or years, which leads to continuous therapeutic efficacy and tumor control. Efforts are underway to expand the repertoire of cancers that can be treated by CAR T cells through identifying new target antigens in solid tumors. The success of CAR T cells has also fueled interest in expanding their application beyond cancer. CAR T cells are demonstrating high response rates in autoimmune diseases and are being investigated as potential treatments for additional disorders, including fibrosis, senescence-associated pathologies and infectious diseases. The next set of 2024 Canada Gairdner International Award laureates are: Shankar Balasubramanian, FRSHerchel Smith Professor of Medicinal Chemistry, Yusuf Hamied Department of Chemistry, University of Cambridge David Klenerman, FRS, FmedSciProfessor of Biophysical Chemistry, Yusuf Hamied Department of Chemistry, University of Cambridge Pascal Mayer, PhDCEO and Co-founder of Alphanosos; Honorary Chair at the Institute for Advanced Study of the University of Strasbourg (USIAS) Awarded “For the fundamental and applied research that led to a revolutionary and affordable method to sequence DNA on a massive scale, which has dramatically accelerated discoveries in the life sciences and medicine” The Work: Balasubramanian, Klenerman and Mayer are recognized for developing the underlying methodologies that led to Solexa-Illumina Next Generation DNA Sequencing (NGS), a technology that has enhanced our basic understanding of life, converting biosciences into ‘big science’ by enabling fast, accurate, low-cost and large-scale genome sequencing – the process of determining the complete DNA sequence of an organism. Balasubramanian and Klenerman’s original work involved methods to observe a single molecule of DNA polymerase incorporating fluorescently labelled DNA monomers onto a growing strand of DNA hybridised to an immobilised template. They had the vision to see how this science could be extended and applied to sequencing a vast array of immobilised DNA molecules in a way that would bring huge benefits of scale, speed and cost. They co-founded the company Solexa, later acquired by Illumina, to make the technology available to the world. Mayer conceived and performed the initial development of 'DNA colony-based massively parallel sequencing by synthesis', initially at Glaxo-Wellcome’s and Serono’s research institutes in Geneva, and finally at a spin-off company, Manteia Predictive Medicine, where he was Chief Scientific Officer. This cluster technology is a key component of the Solexa-Illumina massively parallel sequencing technology. Manteia and its intellectual property were acquired in 2004 by Solexa. NGS has had – and continues to have – a transformative impact in the fields of genomics, biology and medicine. It has allowed a million-fold improvement in speed and cost when compared to the first sequencing of the human genome. In 2000, sequencing of one human genome took over 10 years and cost more than a billion dollars; today, the entire genome of multiple humans can be sequenced in a single day at a cost of less than $1,000. More than a million human genomes have been sequenced, and continue to be sequenced at scale each year, as well as genomes of animals, plants, bacteria and viruses, providing unprecedented insights into genome variation across the planet. The Impact: NGS has had an enormous impact on life sciences. Many aspects of the basic research into mechanisms in living systems now routinely involve high-throughput sequencing of DNA or RNA as the primary readout. Clinical research is undergoing a revolution via the application of genome sequencing, and genomic applications more generally, to discover the underlying causes and markers of diseases, along with substantial new knowledge on the genetic causes and signatures of cancers. There is a wave of new clinical diagnostics emerging for cancers, rare genetic diseases and infectious diseases enabled by NGS of patient samples that now includes minimally invasive blood sampling. During the COVID-19 pandemic, NGS was essential to the rapid understanding of the viral cause of the disease, and then in identifying and monitoring the spread of new variants. Without this technique, progress towards developing vaccines and other interventions would have been slow. It is difficult to overstate the importance and impact of NGS. It has initiated a revolution in biology, enabling the revelation of unsuspected genetic diversity in humans and their pathogens, with major implications, from cell and microbiome biology to ecology, forensics and personalized medicine. 2024 John Dirks Canada Gairdner Global Health Award The 2024 John Dirks Canada Gairdner Global Health Award laureate is recognized for outstanding achievements in global health research: Gagandeep Kang, FRSAdjunct Professor, Christian Medical College, Vellore, India; Director, Enteric, Diagnostics, Genomics and Epidemiology, Bill and Melinda Gates Foundation Awarded “For extensive cohort-based epidemiological, environmental and clinical trial research on enteric diseases in children and their effects on life course, with significant impact on vaccine development and health policy in India and internationally.” The Work: Gagandeep Kang received her training in medicine and microbiology at the Christian Medical College (CMC), Vellore, in southern India. She is Professor of Microbiology at CMC, where her research group has established substantial community-based birth cohort studies addressing childhood enteric infections, growth, and development for over 20 years. Using data and insights from these studies, alongside immunological, mechanistic, epidemiological and implementation research, Prof. Kang has generated extensive information on the complex interactions between the environment and infections in children, and the influence of prior infections on subsequent responses to vaccination. Through extensive, cross disciplinary work drawing on field epidemiology, molecular understanding of infectious agents and infections, clinical trials and policy implementation, she explored the complex relationships between enteric diseases, gut function, and physical and cognitive development in affected children. Prof. Kang conducted the largest single birth cohort study on rotaviral infections in the world, demonstrating that protection after a natural infection is lower in India than in developed countries, which has important implications for the control of diseases by vaccination. As a physician-scientist, Prof. Kang has led key studies that contributed to the development and introduction of two Indian rotavirus vaccines into the national immunization program. These vaccines are now WHO prequalified and their introduction has begun in countries beyond India. She has expanded her research and collaborations to work on other enteric pathogens, particularly cholera and typhoid, with a view to further vaccine introductions; on nutritional and pharmacological interventions aimed at improving oral vaccine efficacy; and on the transmission and impact of, and vaccine effectiveness for COVID-19 in the Indian context. The Impact: Gagandeep Kang has built an internationally recognized and competitive research program centred in India that prioritizes Indian needs while providing valuable and translatable insights to other regions affected by enteric infections. In addition to understanding the mechanism of infection and its effects on individuals, Kang’s group has used geographic information systems to connect virus prevalence at the community level to cost of illness studies, resulting in India becoming the only low-income country with comprehensive disease burden estimates for which cost-effectiveness of vaccination for multiple clinical outcomes could be predicted, as well as new vaccine roll-out programs. By 2019, all 26 million children born annually in India were eligible to receive the rotavirus vaccine, which has the potential to reduce infections, associated complications and death of vulnerable children. In addition to excellent scientific research, Prof. Kang is an exemplary leader. Her approach to clinical and public health research uses a community base to identify problems that need to be addressed through laboratory science in India, and as needed, through international collaborations. In addition to her work in Vellore, India, she took on the challenge of leading the Department of Biotechnology’s Translational Health Science and Technology Institute (THSTI) from 2016 to 2020 to establish the translational science systems needed in the Indian medical research ecosystem. The programs initiated at the Institute have been critical to supporting the multiple vaccine development efforts of Indian vaccine manufacturers and have received global recognition. 2024 Canada Gairdner Momentum Award The 2024 Canada Gairdner Momentum Award laureates are mid-career investigators recognized for exceptional scientific research contributions with continued potential for impact on human health. Meghan Azad, PhDProfessor, Pediatrics and Child Health, University of Manitoba; Research Scientist, Children’s Hospital Research Institute of Manitoba; Director of Science & Knowledge Mobilization, THRiVE Discovery Lab; Co-Director, Manitoba Interdisciplinary Lactation Centre (MILC); Canada Research Chair, Early Nutrition and the Developmental Origins of Health and Disease Awarded “For research on understanding how human breast milk contributes to shaping the infant microbiome and lifelong health.” The Work: Dr. Azad is leading innovative research about breastfeeding, human breast milk and the microbiome. While previous studies have often been underpowered, narrowly focused on single milk components, inconsistent in their definition of “breastfeeding”, and limited by confounding (e.g. the socioeconomic status) issues, Dr. Azad’s research is addressing these nuances and shortcomings to provide new insights on how infant feeding practices and hundreds of different breast milk components influence health and disease throughout the life cycle. Studying over 3,000 children, Dr. Azad’s team has shown that longer and more exclusive breastfeeding is associated with healthier body composition and reduced risk of asthma. Further, their studies have provided novel evidence that the method of feeding (i.e. pumping vs. nursing at the breast) matters – possibly because bioactive milk compounds degrade in storage. Indeed, her team found that pump extraction affects the human milk microbiome and bacteria sharing between mothers and infants. The Impact: Dr. Azad is a renowned research leader whose groundbreaking work is pushing the boundaries of knowledge generation and translation in the important areas of infant nutrition, lactation, maternal-child health, and the developmental origins of disease. Moreover, she is highly dedicated to enriching the scientific community in Canada through her commitment to recruiting and training new researchers, supporting science literacy among Canadian children and the general public, and engaging Canadian policymakers to foster support for science and evidence-based policy-making. Meghan Azad is Professor of Pediatrics and Child Health at the University of Manitoba. She holds a Canada Research Chair in Early Nutrition and the Developmental Origins of Health and Disease, and she co-directs the THRiVE Discovery Lab, where her team studies how early life nutrition shapes the infant microbiome and child health. She co-founded the Manitoba Interdisciplinary Lactation Centre (MILC) and leads several interdisciplinary research teams, including the International Milk Composition (IMiC) Consortium (7 countries, 18 investigators, 1200 mother-infant pairs). In addition, she is Deputy Director of the CHILD Cohort Study, an ongoing longitudinal Canadian birth cohort of 3500 families. In 2022, she received the Steacie Prize for early career researchers. Christian Landry, Prof. Professor of biology and biochemistry, Laval University; Canada Research Chair in Cellular Systems and Synthetic Biology Awarded “For the development of novel approaches that combine synthetic biology, experimental evolution, and systems biology to address fundamental questions about gene function relevant to health and human disease." The Work: Prof. Landry’s research group is integrating cutting-edge approaches in genetics, genomics, systems biology and bioinformatics to answer one of the most long-lasting questions in biology and biomedical research: how mutations change the way cells work and alter their performance. Understanding the principles by which mutations translate into phenotypes is at the core of human genetics and other fields such as evolutionary biology and biotechnology. The overarching goal of Prof. Landry’s team is to probe the robustness and function of cellular networks, with the long-term objective of better understanding how individual variation such as mutations cause changes in complex traits and, ultimately, diseases. Over the past six years, it has developed numerous high-throughput tools that allow the investigation of entire protein interaction networks, how these networks can be rewired by mutations, and how their past evolution may influence the outcomes of disease mutations. The Impact: Christian Landry has brought an entirely new perspective to systems biology, in which networks, such as protein-protein interactions, and cellular signaling, are investigated in the context of historical evolutionary forces in order to better understand their fundamental properties. His work is of critical importance to health and human disease since all organisms evolve through the same principles, including pathogens impacting humans. His recent research has ranged from investigations of the evolution of resistance to antifungal drugs, host-pathogen arms races, and evolutionary trade-offs in cellular processes and networks, to systems biology studies of microbial interactions. In the long term, systematic analyses of mutations causing variations in complex phenotypes such as drug resistance will enable the development of drugs that are less likely to lead to resistance, which is key in the context of limited treatment options. Prof. Landry was elected in the inaugural cohort of the College of the Royal Society of Canada; he received the NSERC EWR Steacie Memorial Award for early career researchers in 2017 and the SMBE Mid-career Award for outstanding contributions in 2020. In 2021, he received Laval University's Excellence Prize for teaching and mentoring to graduate students and postdocs. He is also contributing to changing the way science is published and communicated through his work as Senior Editor for eLife and editorial advisor for EMBO Review Commons, two organizations actively involved in remodelling the scientific publication landscape to make it more transparent and equitable. About the Gairdner Foundation Established in 1957, the Gairdner Foundation is dedicated to fulfilling James A. Gairdner’s vision to recognize major research contributions to the treatment of disease and alleviation of human suffering. Through the prestigious annual Canada Gairdner Awards, the Foundation celebrates the world’s most creative and accomplished researchers whose work is improving the health and wellbeing of people around the world. Since its inception, 418 awards have been bestowed on laureates from over 40 countries, and of those awardees, 98 have gone on to receive Nobel Prizes. The Gairdner Foundation believes in coming together to openly discuss science in order to better engage the public, understand the problems we face, and work together to find solutions. Since its founding, a number of outreach events and programs have been developed with the goal of inspiring the next generation of scientific innovators and fostering an informed society. https://www.gairdner.org/ For further information, please contact:Sommer WedlockExecutive Vice PresidentGairdner Foundationsommer@gairdner.org